Innovative Trial Designs Emerge After Immunotherapy Setbacks in Head and Neck Cancer
• Recent phase 3 trials KEYNOTE-412 and JAVELIN Head and Neck 100 failed to show survival benefits when adding immunotherapy to chemoradiotherapy in locally advanced head and neck cancer, prompting researchers to investigate alternative treatment sequences.
• Emerging data from phase 2 trials suggests that sequential rather than concurrent immunotherapy administration may be more effective, with neoadjuvant pembrolizumab showing promising pathological response rates and improved disease-free survival.
• The phase 3 KEYNOTE-689 trial recently demonstrated statistically significant improvement in event-free survival with perioperative pembrolizumab, potentially establishing a new standard of care for resectable locally advanced head and neck squamous cell carcinoma.
Nivolumab Plus Cisplatin-Radiotherapy Improves Disease-Free Survival in Advanced Head and Neck Cancer
• The Phase 3 NIVOPOSTOP trial demonstrated that adding nivolumab to standard cisplatin-radiotherapy significantly improved disease-free survival (DFS) in patients with resected, locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
• The study showed a statistically significant and clinically meaningful improvement in DFS for patients receiving nivolumab compared to those receiving cisplatin-radiotherapy alone, marking a potential shift in the standard of care.
• A trend toward improved overall survival (OS) was observed with nivolumab, with final OS analysis pending, and the safety profile of nivolumab was consistent with previous studies.
• The findings suggest that adjuvant nivolumab could be practice-changing for high-risk LA-SCCHN patients, offering a new treatment option after surgery to reduce the risk of relapse.
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